3
Copyright JCAHO LD.5.2 Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.

4
Copyright JCAHO Requirements of LD.5.2 At least annually, select at least one high-risk process for proactive risk assessment such selection to be based, in part, on information published periodically by the Joint Commission that identifies the most frequently occurring types of sentinel events and patient safety risk factors

5
Copyright JCAHO High Risk Processes PI.4.2 – Processes that involve risks or may result in sentinel events Medication Use Operative and other procedures Use of blood and blood components Restraint use Seclusion, when a part of care Care/services provided to high-risk populations Resuscitation

6
Copyright JCAHO The Medication Use Process Selection, Procurement, and Storage Prescribing or Ordering, and Transcribing Preparing and Dispensing AdministrationMonitoring

7
Copyright JCAHO Requirements of LD.5.2 Conduct a Failure Mode and Effects Analysis (FMEA) Assess the intended and actual implementation of the process to identify the steps in the process where there is, or may be, undesirable variation (i.e., what engineers call potential "failure modes")

8
Copyright JCAHO Step 1 Construct a Detailed Flow Chart of the Process Multi-disciplinary participation of all those involved in the process Allocate plenty of time for this step Be as detailed and complete as possible Learn the flow chart process and symbols Flow charting software can help

9
Copyright JCAHO Step 2 Determine each step that can “fail” and how it can “fail” Physician Writes Order Medication Order Order Pulled From Chart Order Transcribed By Unit Clerk into MAR Order Transcribed By Pharm Tech Into Pharmacy System NCR copy of order sent to pharmacy Writing illegible Order incomplete Non-formulary drug Used felt pen Confusion abbrev. used Look-alike drug ordered Contrary to approved clinical protocol Order not pulled in Timely manner Transcription error

10
Copyright JCAHO Requirements of LD.5.2 For each identified "failure mode" identify the possible effects on patients (what engineers call the "effect"), and how serious the possible effect on the patient could be (what engineers call the "criticality" of the effect)

13
Copyright JCAHO Occurrence Scale LikelihoodProbability Remote (1)1 in 10,000 No known occurrence Low (2, 3, 4)1 in 5,000 Possible, but no known data Moderate (5, 6)1 in 200 Documented but infrequent High (7, 8)1 in 100 Documented and frequent Very High (9, 10)1 in 20 Documented, Almost certain

15
Copyright JCAHO Detection Scale LikelihoodProbability Very High (1)9 out of 10 Error always detected High (2, 3)7 out of 10 Error likely to be detected Moderate (4, 5, 6)5 out of 10 Moderate likelihood of detection Low (7, 8)2 out of 10 Low likelihood of detection Remote (9)0 out of 10 Detection not possible at any point

20
Copyright JCAHO Requirements of LD.5.2 Redesign the process and/or underlying systems to minimize the risk of that failure mode or to protect patients from the effects of that failure mode

21
Copyright JCAHO Step 6 Brainstorm actions that could reduce the criticality index starting with failure modes that have the highest CI value that: Decrease likelihood of occurrence Decrease the severity of effects Increase the probability of detection

22
Copyright JCAHO Requirements of LD.5.2 Pilot test and implement the redesigned process. Identify and implement measures (indicators) of the effectiveness of the redesigned process.

23
Copyright JCAHO Requirements of LD.5.2 Implement a strategy for maintaining the effectiveness of the redesigned process over time.

24
Copyright JCAHO Note similarities to PI PI.2 The new/modified process is designed well. PI.2.1 Performance expectations are established for new/modified processes PI.2.2 The performance of new/modified processes is measured PI.5Improved performance is achieved and sustained over time

25
Copyright JCAHO Remember Take small bites – keep it simple. FMEA on PCA Think: “what could possibly go wrong” Or what has gone wrong frequently in past Any modification to the process, creates new risk points.

26
Copyright JCAHO Parting Thought On survey, JCAHO is currently not evaluating how good your FMEA process is. JCAHO is evaluating whether you used a proactive process (that includes the elements of the intent) to determine risk points and then took action to reduce the risk